Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)

The Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) is a shoulder joint replacement implant designed for patients with a functional deltoid muscle and massive, non-repairable rotator cuff tears caused by conditions such as rheumatoid arthritis, osteoarthritis, avascular necrosis, humeral head fractures, or traumatic arthritis. The glenoid implant consists of a baseplate with a press-fit post, peripheral anchoring screws, and a glenosphere that is anchored to bone with screws for non-cemented fixation.

The Perform Mono shares the same intended use and principle of operation as predicate devices. Key differences include an additional range of glenoid baseplates with metallic augmentation and baseplates for BIO-RSA technique, along with associated instruments to accommodate specific patterns of glenoid wear in patients.

Not stated in this summary.

Substantial equivalence is supported by non-clinical performance testing including fatigue testing, pull-out testing, loosening testing, range of motion evaluation, biocompatibility evaluation, cadaveric lab testing, packaging and shelf-life evaluations, sterilization evaluation, MRI compatibility evaluation, and fretting corrosion evaluation. No clinical studies were performed. The device does not raise different questions of safety or effectiveness, and performance testing results support substantial equivalence to the predicate Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid (K161742).